MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-24 for PAKAUTO 303467 manufactured by Immucor Gti Diagnostics, Inc..
[125774862]
Patient Sequence No: 1, Text Type: N, H10
[125774863]
(b)(6) 2018. The customer returned kit from lot 3006837 (pa) was tested in parallel with an immucor-wks retention kit from lot 3006837 (pa) on (b)(6) 2018. The customer returned kit and the retention kit from lot 3006837 (pa) gave negative control od average values in the iib/iiia rows that did not meet ifu validity criteria. The negative serum control is run in duplicate with each test run. The negative serum control should give an average od value of < or equal to 0. 160 od in the iib/iiia rows. The customer complaint ((b)(4)) was reproduced. The customer was performing validation and study testing using the kit. Corrective action is being taken through fa-wks-18-008, to notify customers of the affected pakauto lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00031 |
| MDR Report Key | 8002478 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-24 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-09-20 |
| Device Manufacturer Date | 2018-05-09 |
| Date Added to Maude | 2018-10-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT VOIGTS |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541006 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53186 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAKAUTO |
| Generic Name | PAKAUTO |
| Product Code | MYP |
| Date Received | 2018-10-24 |
| Returned To Mfg | 2018-09-27 |
| Catalog Number | 303467 |
| Lot Number | 3006837 |
| Device Expiration Date | 2019-12-15 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-24 |